Kit Howard

Background

About Kit Howard

Multi-faceted professional with over 30 years of experience in clinical research, with broad and in-depth expertise in developing clinical data standards for drugs, biologics and medical device clinical trials, especially those based on CDISC. Extensive experience in cross-functional global team leadership, management and facilitation, specializing in process improvement projects. Excellent grasp of the entire drug development process, particularly with respect to the scientific / operational interface in clinical development. Strong communication and interpersonal skills, and a talent for developing compelling visions for change. Specialties:* Clinical data standards development, implementation and maintenance;* CDISC standards expert, including CDASH, SDTM and Devices;* Educational program and materials development and delivery for CDASH, SDTM, clinical data standards, data quality, clinical data management; Data Lifecycle Plan (DLP) expert;* Standards auditing for conformance to external and/or internal clinical data standards * Data quality process and tool development, auditing and training;* Data management auditing for sponsors, service providers and academic research organizations;